(154 days)
The XIA® 4.5 Spinal System is intended for posterior noncervical pedicle fixation for the following indications: severe spondylolisthesis (i.e. Grades 3 and 4 at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment), trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
The XIA 4.5 Spinal System is also intended for anterolateral and posterior, non-cervical, non-pedicle fixation for the following indications: degenerative disc disease (defined as back pain of discogenic origin with degeneration of the disc confirmed by history and radiographic studies), spondylolisthesis, trauma (i.e. fracture or dislocation), spinal stenosis, curvatures (i.e. scoliosis, kyphosis, and/or lordosis), tumor, pseudoarthrosis and failed previous fusion.
The Stryker Spine Xia 4.5 Spinal System offers a comprehensive solution for immobilizing and stabilizing spinal deformities in patients, particularly those with a smaller stature, as an adjunct to fusion. The Stryker Spine Xia® 4.5 Spinal System is comprised of Ø 4.5 mm rods, Polyaxial and Monoaxial screws, Blockers, Hooks, Dual Staples, and Connectors. The components are available in a variety of diameters and lengths in order to accommodate patient anatomy and are fabricated from titanium alloy. The implants will be provided non-sterile and will be used for either posterior or anterolateral non cervical fixation.
The provided document does not contain specific acceptance criteria or a detailed study report that would allow for a complete description of the acceptance criteria and a study proving device performance as requested.
However, based on the information provided, here's what can be extracted and inferred:
1. Table of Acceptance Criteria and Reported Device Performance:
The document states: "Mechanical testing demonstrated comparable mechanical properties to the predicate devices." This implies that the acceptance criteria for the Xia 4.5 Spinal System were based on its mechanical properties being equivalent or superior to those of its predicate devices.
| Acceptance Criterion | Reported Device Performance |
|---|---|
| Mechanical Properties | Comparable to predicate devices (Stryker Spine Xia Spinal System (K002858), DePuy Spine MOSS Miami™ Spinal System (K950697 and K962628), and Medtronic Sofamor Danek CD Horizon Legacy™ (K020709)). |
Detailed Study Information (Not Present in the Document):
The document is a 510(k) summary, which focuses on demonstrating substantial equivalence to predicate devices, rather than providing a detailed clinical study report with acceptance criteria, human reader studies, or ground truth establishment. Therefore, most of the requested information regarding sample size, data provenance, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth for training sets is not available in this document.
Here's why each specific point cannot be addressed:
- 2. Sample size used for the test set and the data provenance: Not mentioned. The "comparable mechanical properties" likely refer to bench testing, not a clinical test set.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. This level of detail is for clinical studies, which are not described here.
- 4. Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- 5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is a spinal fixation system, not an AI-driven diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done: Not applicable. This is a physical medical device.
- 7. The type of ground truth used (expert consensus, pathology, outcomes data, etc): For mechanical testing, the "ground truth" would be the established mechanical performance standards or previously validated mechanical properties of the predicate devices.
- 8. The sample size for the training set: Not applicable. This is a physical device, not an AI model.
- 9. How the ground truth for the training set was established: Not applicable.
Summary of what is available:
- Device: Xia 4.5 Spinal System
- Proof of Meeting Criteria: "Mechanical testing demonstrated comparable mechanical properties to the predicate devices."
- Nature of Study: A substantial equivalence review based on mechanical (bench) testing, comparing the subject device to existing predicate devices. This is a standalone performance evaluation in the context of mechanical properties, not for an AI algorithm.
- Ground Truth for the study: The established mechanical properties of the predicate devices.
- Outcome: The FDA determined the device to be substantially equivalent to legally marketed predicate devices, allowing it to proceed to market.
§ 888.3070 Thoracolumbosacral pedicle screw system.
(a)
Identification. (1) Rigid pedicle screw systems are comprised of multiple components, made from a variety of materials that allow the surgeon to build an implant system to fit the patient's anatomical and physiological requirements. Such a spinal implant assembly consists of a combination of screws, longitudinal members (e.g., plates, rods including dual diameter rods, plate/rod combinations), transverse or cross connectors, and interconnection mechanisms (e.g., rod-to-rod connectors, offset connectors).(2) Semi-rigid systems are defined as systems that contain one or more of the following features (including but not limited to): Non-uniform longitudinal elements, or features that allow more motion or flexibility compared to rigid systems.
(b)
Classification. (1) Class II (special controls), when intended to provide immobilization and stabilization of spinal segments in skeletally mature patients as an adjunct to fusion in the treatment of the following acute and chronic instabilities or deformities of the thoracic, lumbar, and sacral spine: severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra; degenerative spondylolisthesis with objective evidence of neurologic impairment; fracture; dislocation; scoliosis; kyphosis; spinal tumor; and failed previous fusion (pseudarthrosis). These pedicle screw spinal systems must comply with the following special controls:(i) Compliance with material standards;
(ii) Compliance with mechanical testing standards;
(iii) Compliance with biocompatibility standards; and
(iv) Labeling that contains these two statements in addition to other appropriate labeling information:
“Warning: The safety and effectiveness of pedicle screw spinal systems have been established only for spinal conditions with significant mechanical instability or deformity requiring fusion with instrumentation. These conditions are significant mechanical instability or deformity of the thoracic, lumbar, and sacral spine secondary to severe spondylolisthesis (grades 3 and 4) of the L5-S1 vertebra, degenerative spondylolisthesis with objective evidence of neurologic impairment, fracture, dislocation, scoliosis, kyphosis, spinal tumor, and failed previous fusion (pseudarthrosis). The safety and effectiveness of these devices for any other conditions are unknown.”
“Precaution: The implantation of pedicle screw spinal systems should be performed only by experienced spinal surgeons with specific training in the use of this pedicle screw spinal system because this is a technically demanding procedure presenting a risk of serious injury to the patient.”
(2) Class II (special controls), when a rigid pedicle screw system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion in the treatment of degenerative disc disease and spondylolisthesis other than either severe spondylolisthesis (grades 3 and 4) at L5-S1 or degenerative spondylolisthesis with objective evidence of neurologic impairment. These pedicle screw systems must comply with the following special controls:
(i) The design characteristics of the device, including engineering schematics, must ensure that the geometry and material composition are consistent with the intended use.
(ii) Non-clinical performance testing must demonstrate the mechanical function and durability of the implant.
(iii) Device components must be demonstrated to be biocompatible.
(iv) Validation testing must demonstrate the cleanliness and sterility of, or the ability to clean and sterilize, the device components and device-specific instruments.
(v) Labeling must include the following:
(A) A clear description of the technological features of the device including identification of device materials and the principles of device operation;
(B) Intended use and indications for use, including levels of fixation;
(C) Identification of magnetic resonance (MR) compatibility status;
(D) Cleaning and sterilization instructions for devices and instruments that are provided non-sterile to the end user; and
(E) Detailed instructions of each surgical step, including device removal.
(3) Class II (special controls), when a semi-rigid system is intended to provide immobilization and stabilization of spinal segments in the thoracic, lumbar, and sacral spine as an adjunct to fusion for any indication. In addition to complying with the special controls in paragraphs (b)(2)(i) through (v) of this section, these pedicle screw systems must comply with the following special controls:
(i) Demonstration that clinical performance characteristics of the device support the intended use of the product, including assessment of fusion compared to a clinically acceptable fusion rate.
(ii) Semi-rigid systems marketed prior to the effective date of this reclassification must submit an amendment to their previously cleared premarket notification (510(k)) demonstrating compliance with the special controls in paragraphs (b)(2)(i) through (v) and paragraph (b)(3)(i) of this section.